Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Patients Who Have Undergone Radiation Therapy for Cancer

NCT00077090 | Unknown Phase 2

• 3 other identifiers: CDR0000349496RMNHS-HOTEU-20337
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Hyperbaric oxygen therapy may be effective in repairing damaged tissue and reducing lymphedema caused by radiation therapy for cancer. PURPOSE: This randomized phase II trial is studying hyperbaric oxygen to see how well it works compared to standard therapy in treating chronic arm lymphedema in patients who have undergone radiation therapy for cancer.

Conditions

Breast Cancer; Lymphedema; Perioperative/Postoperative Complications; Radiation Fibrosis

Keywords

lymphedema; radiation fibrosis; perioperative/postoperative complications; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• Volume of the affected limb, expressed as a percentage of the contralateral limb Volume on the day of measurement, as measured by perometer 12 months after baseline assessment

Secondary Outcomes (3)

• Patient self-assessments, using specific quality of life scale in upper limb lymphoedema and the UK SF-36 Health Survey Questionnaire, at 3, 6, 9 and 12 months after baseline assessment

• 99Tc-nanocolloid clearance rate as measured by quantitative lymphoscintigraphy 12 months after baseline assessment

• Extracellular water content as measured by EdemaMeter (bioimpedance measurements) 12 months after baseline assessment

Interventions

hyperbaric oxygen DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * History of early breast cancer (T1-3, N0-1, M0) * Prior breast surgery with or without axillary dissection * Prior breast/chest wall radiotherapy with or without radiotherapy to the supraclavicular fossa and/or axilla, completed at least 2 years ago * Arm lymphedema * At least 15% increase in arm volume * No evidence of cancer recurrence * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * Over 18 Sex * Female or male Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Pulmonary * No chronic obstructive airway disease * No bullous lung disease * No acute or chronic pulmonary infection * No uncontrolled asthma * No untreated pneumothorax Other * Physically and psychologically fit for HBO therapy * No claustrophobia * No epilepsy * No eustachian tube dysfunction * No recurrent attacks of vertigo * No contraindication to MRI (e.g., intracranial ferrous material) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics * No prior ear operations Other * No prior hyperbaric oxygen (HBO) therapy, except as treatment for decompression illness

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (5)

Royal Hospital Haslar

Gosport, England, PO12 2AA, United Kingdom

Location

Hull Royal Infirmary

Hull, England, HU3 2KZ, United Kingdom

Location

London Hyperbaric Medicine Limited at Whipps Cross Hospital

London, England, E11 1NR, United Kingdom

Location

Diving Diseases Research Centre

Plymouth, England, PL6 8BU, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema; Postoperative Complications; Radiation Fibrosis Syndrome

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• John R. Yarnold, MD, FRCR

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 11, 2004
• Study Start: April 1, 2004
• Last Updated: December 18, 2013

Record last verified: 2007-09

Locations

GB (5)